Not provided
Not provided
Not provided
Not provided
Not provided
Transfer of IND to different marketing authorization representative.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
MP-101 will be evaluated in this study to see if it is safe and tolerable.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Subjects | Experimental | Assigned to receive open-label 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized) | Drug | 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events | Up to 120 Days |
Not provided
Not provided
Inclusion Criteria:
Be male or female adults, 18 years of age or older
Have SBS that is inadequately controlled on current antidiarrheal medication (e.g., loperamide or diphenoxylate), including subjects with ileostomies
Must have been deemed a completer of study protocol MP-101-CL-001.
Males or non-pregnant, non-lactating females who are postmenopausal, naturally or surgically sterile, or who agree to use effective contraceptive methods throughout the course of the study. Postmenopausal is defined as at least 12 months of natural spontaneous amenorrhea, or at least 6 weeks following surgical menopause (bilateral oophorectomy)
Females of childbearing potential must agree to use 1 of the following acceptable birth control methods:
Females of childbearing potential must have a negative serum human chorionic gonadotropin (hCG) pregnancy test at Visit 1.
Be able to understand and provide signed informed consent
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States | ||
| Indiana University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Regional Infectious Disease Infusion Center | Lima | Ohio | 45801 | United States |
| Vanderbilt Center for Human Nutrition | Nashville | Tennessee | 37212-1150 | United States |
| ID | Term |
|---|---|
| D012778 | Short Bowel Syndrome |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided